Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction "CHARM"

Not yet recruiting

Phase 3 Results N/A

Trial Description

This study evaluates the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.

Detailed Description

This study, previously posted by Remedy Pharmaceuticals, Inc., has transitioned to Biogen with the acquisition of CIRARA.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Administered as specified in the treatment arm.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.
  • CIRARA (glyburide for injection) Drug
    ARM 1: Kind: Experimental
    Label: CIRARA
    Description: CIRARA (glyburide for injection)
  • Placebo (for CIRARA) Drug
    ARM 1: Kind: Experimental
    Label: Placebo for CIRARA
    Description: Placebo (for CIRARA)
  • BIIB093 Drug
    Other Names: glibenclamide; glibenclamide intravenous (IV); glyburide; CIRARA
    Intervention Desc: Administered as specified in the treatment arm.
    ARM 1: Kind: Experimental
    Label: BIIB093
    Description: BIIB093 administered as a bolus followed by continuous intravenous (IV) infusion over 72 hours.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of participants with improvement in functional outcome at 90 days assessed via the modified Rankin Scale Change from baseline at 90 days No
Secondary Proportion of participants with improvement in overall survival at 90 days Change from baseline at 90 days No
Secondary Proportion of participants with a reduction in midline shift at 72 hours assessed via non-contrast computed tomography Change from baseline at 72 hours No
Secondary Safety of CIRARA via collection of adverse events and serious adverse events Change from baseline through 15 days Yes
Primary Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS) Baseline up to Day 90
Secondary Time to All-Cause Death Baseline up to Day 90
Secondary Proportion of Participants Who Achieved mRS 0-4 at Day 90 Baseline up to Day 90
Secondary Reduction in Midline Shift at 72 Hours Baseline up to 72 hours
Secondary Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Day 90

Sponsors